UAB - Center for Clinical and Translational Science

o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL: - AVA >1.0 cm² and <1.5cm²; or - AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²: or - AVA ≤ 1.0 cm² with AVAI > 0.5cm²/m² if BMI ≥ 30 kg/m²: and - Max aortic velocity ≥ 3.0 m/sec. and < 4.0 m/sec. or - Mean aortic gradient ≥ 20mmHg and < 40.0 mmHg Any of the following at-risk features: - Symptoms of AS, defined as: - NYHA ≥ Class II, or - Reduced functional capacity, defined as - 6MWT < 300 meters, or - < 85% of age-sex predicted METs on exercise tolerance testing (ETT) - Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent - NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or - Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or - Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or - Any of the following by the qualifying TTE as assessed by the ECL: - Global longitudinal strain ≤16% (absolute value), or - E/e' ≥ 14.0 (average of medial and lateral velocities), or - Diastolic dysfunction ≥ Grade II, or - LVEF < 60% - Stroke Volume Index < 35 ml/m² - Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system - The subject and the treating physician agree the subject will return for all required follow-up visits

• Age < 65 years - LVEF ≤ 20% by 2-D echo - Class I indication for cardiac surgery - Contraindication for placement of a bioprosthetic valve - Documented history of cardiac amyloidosis